BASEL (dpa-AFX) - Novartis AG (NVS) said a decision to terminate ALTITUDE trial has been taken on the recommendation of the independent Data Monitoring Committee, or DMC, overseeing the trial, following the seventh interim review of data from the ALTITUDE study with Rasilez/Tekturna.
According to the company, the ALTITUDE study involved patients with type 2 diabetes and renal impairment who are at high risk of cardiovascular and renal events.
The DMC concluded that patients were unlikely to benefit from treatment added on top of standard anti-hypertensives, and identified higher adverse events in patients receiving Rasilez/Tekturna in addition to standard of care in the trial. Specifically, in the trial arm in which Rasilez/Tekturna was added to the standard of care there was an increased incidence after 18-24 months of non-fatal stroke, renal complications, hyperkalemia and hypotension in this high-risk study population.
Novartis also said it is in ongoing talks with health authorities worldwide about the implications of the findings from ALTITUDE for patients. As a precautionary measure Novartis will cease promotion of Rasilez/Tekturna-based products for use in combination with an angiotensin converting enzyme, or ACE-inhibitor or angiotensin receptor blocker, or ARB.
'Patient safety is the highest priority for Novartis, and we are in a dialogue with health authorities worldwide,' said David Epstein, Division Head of Novartis Pharmaceuticals.
Copyright RTT News/dpa-AFX